This is a phase II, single-centre, open-label pilot study evaluating the safety and tolerability of anifrolumab in adult patients with primary antiphospholipid syndrome (APS). Approximately 20 participants will receive 120 mg subcutaneous anifrolumab once weekly for up to 52 weeks in addition to their standard of care treatment.
The primary objective is to assess the incidence of adverse events during treatment. Secondary and exploratory objectives include evaluation of immunological parameters, thromboinflammatory markers, and patient-reported outcomes. Participants will be followed for an additional 12-week safety follow-up period after completion of treatment.
Provision of written informed consent (ICF) prior to any study-specific procedures.
Females/males aged 18 to 70 years at Screening (at the time of ICF signing).
Weight ≥40.0 kg at Screening.
Classified as having primary APS as per the 2023 ACR/EULAR APS classification criteria, i.e. fulfilling at least one documented clinical criterion [ie., macrovascular (venous thromboembolism and/or arterial thrombosis), established microvascular (livedoid vasculopathy, aPL nephropathy, pulmonary haemorrhage or myocardial disease), cardiac valve (valve thickening or valve vegetation) and/or haematology (thrombocytopenia)] and at least one laboratory criterion and scoring at least three points in each of the clinical and laboratory domains.
Any condition that, in the opinion of the Investigator, would interfere with the efficacy or safety evaluation of the study intervention or put the participant at safety risk.
Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Current participation in another clinical study with an IP.
Lactating or pregnant females or females who intend to become pregnant anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).
National and Kapodistrian University of Athens
Lead sponsor
AstraZeneca
Collaborator